Trial Outcomes & Findings for Evaluation of BiCROS Fitting Benefits (NCT NCT05379231)
NCT ID: NCT05379231
Last Updated: 2025-06-11
Results Overview
Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker and noise from the better ear's side with the US matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A)). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 65 dB (A).
COMPLETED
NA
22 participants
At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting
2025-06-11
Participant Flow
2 participants had to be excluded from continuing in the study before assignment because they did not meet the inclusion criteria.
Participant milestones
| Measure |
Complete Sample
All participants first underwent a Home Visit where they all received a BiCROS fitting in the automatic mode, and then underwent an in-lab visit where all participants were randomized and counter-balanced into receiving 5 interventions (BiCROS Fitting with beamformer, BiCROS Fitting Omni, Monaural Fitting with Beamformer, Monaural Fitting Omni, and Unaided) in a different order/sequence.
BiCROS fitting with beamformer: fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer will be enabled during this measurement.
BiCROS fitting omni: fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
Monaural hearing aid fitting with beamformer: fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer will be enabled during the measurement.
Monaural hearing aid fitting omni: fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
Unaided condition: No intervention, the participants are not fitted with a CROS device and/or hearing aid.
|
|---|---|
|
Home Visit
STARTED
|
20
|
|
Home Visit
COMPLETED
|
18
|
|
Home Visit
NOT COMPLETED
|
2
|
|
In-lab Visit
STARTED
|
20
|
|
In-lab Visit
BiCROS Fitting With Beamformer
|
20
|
|
In-lab Visit
BiCROS Fitting Omni
|
20
|
|
In-lab Visit
Monaural Hearing Aid Fitting With Beamformer
|
20
|
|
In-lab Visit
Monaural Hearing Aid Fitting Omni
|
20
|
|
In-lab Visit
Unaided Condition
|
20
|
|
In-lab Visit
COMPLETED
|
18
|
|
In-lab Visit
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Complete Sample
All participants first underwent a Home Visit where they all received a BiCROS fitting in the automatic mode, and then underwent an in-lab visit where all participants were randomized and counter-balanced into receiving 5 interventions (BiCROS Fitting with beamformer, BiCROS Fitting Omni, Monaural Fitting with Beamformer, Monaural Fitting Omni, and Unaided) in a different order/sequence.
BiCROS fitting with beamformer: fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer will be enabled during this measurement.
BiCROS fitting omni: fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
Monaural hearing aid fitting with beamformer: fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer will be enabled during the measurement.
Monaural hearing aid fitting omni: fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
Unaided condition: No intervention, the participants are not fitted with a CROS device and/or hearing aid.
|
|---|---|
|
Home Visit
Withdrawal by Subject
|
2
|
|
In-lab Visit
Withdrawal by Subject
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Complete Sample
n=18 Participants
All participants will perform the same tests in all conditions. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.
BiCROS fitting: Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear.
Monaural hearing aid fitting: Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear.
Unaided condition: No intervention, the participants are not fitted with a CROS device and/or hearing aid.
Since the characteristics of each "arm" are unrelevant for the study outcome, there has been no separate analysis on each "arm".
|
|---|---|
|
Age, Continuous
|
74.6 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=18 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=18 Participants
|
|
BiCROS fitting candidate
|
18 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fittingPopulation: Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears.
Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker and noise from the better ear's side with the US matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A)). The noise will be presented on the better ear at an azimuth of 90° or 270° (depending on the site of the better ear), at a level of 65 dB (A).
Outcome measures
| Measure |
BiCROS With Beamformer
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement.
|
BiCROS Omni
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
|
Monaural With Beamformer
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement.
|
Monaural Omni
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
|
Unaided
n=18 Participants
No hearing aid fitting.
|
|---|---|---|---|---|---|
|
Speech Intelligibility in Noise Measured With US Matrix Test (Noise From a Defined Loudspeaker)
|
-8.8 dBSRT
Standard Deviation 3.4
|
-3.7 dBSRT
Standard Deviation 2.9
|
-9.2 dBSRT
Standard Deviation 2.7
|
-2.8 dBSRT
Standard Deviation 2.5
|
-0.1 dBSRT
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fittingPopulation: Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears.
Measuring the Signal to Noise Ratio change in decibels (dB) for speech from the front loudspeaker in surrounding noise with the US Matrix Test. Results of the speech test will be the SRT (speech recognition threshold) in dB SNR (signal to noise ratio). The target speaker will be presented from 0° azimuth and is adaptive (start level at 65dB (A). The noise will be presented from a circle of 8 surrounding speakers from 45° to 315° at a level of 65 dB (A) with the participant seated in the centre of the circle.
Outcome measures
| Measure |
BiCROS With Beamformer
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement.
|
BiCROS Omni
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
|
Monaural With Beamformer
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement.
|
Monaural Omni
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
|
Unaided
n=18 Participants
No hearing aid fitting.
|
|---|---|---|---|---|---|
|
Speech Intelligibility in Noise Measured With US Matrix Test (Diffuse Noise)
|
-14.2 dBSRT
Standard Deviation 3.3
|
-8 dBSRT
Standard Deviation 4.2
|
-13.9 dBSRT
Standard Deviation 3.6
|
-9.3 dBSRT
Standard Deviation 3
|
-3.4 dBSRT
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fittingPopulation: Although each ear receives a different device configuration, the participant is assigned as a whole, and assignment is not by ears.
Measured after home trial with the Speech, Spatial and Qualities of Hearing Scale-Benefit (Gatehouse, 2004). The scale ranges from -5 to 5, where negative values indicate that the condition under test is worse than the comparator, 0 indicates no change, and positive values indicate a benefit of the condition under test compared to the comparator.
Outcome measures
| Measure |
BiCROS With Beamformer
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement.
|
BiCROS Omni
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
|
Monaural With Beamformer
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement.
|
Monaural Omni
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
|
Unaided
No hearing aid fitting.
|
|---|---|---|---|---|---|
|
Reports of Subjective Quality of Hearing as Assessed by the SSQ
Speech
|
2.48 score on a scale
Standard Deviation 0.59
|
—
|
—
|
—
|
—
|
|
Reports of Subjective Quality of Hearing as Assessed by the SSQ
Spatial
|
1.16 score on a scale
Standard Deviation 0.47
|
—
|
—
|
—
|
—
|
|
Reports of Subjective Quality of Hearing as Assessed by the SSQ
Qualities
|
2.55 score on a scale
Standard Deviation 0.35
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fittingPopulation: Although each ear receives a different device configuration, the participant is assigned as a whole, and assignment is not by ears.
Measured after home trial with the Bern Benefit in Single-Sided Deafness Questionnaire (Komps et al, 2011). The scale ranges from -5 to 5, where negative values indicate that the condition under test is better wihtout the hearing aid, 0 indicates no change, and positive values indicate a benefit with the hearing aid.
Outcome measures
| Measure |
BiCROS With Beamformer
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement.
|
BiCROS Omni
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
|
Monaural With Beamformer
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement.
|
Monaural Omni
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
|
Unaided
No hearing aid fitting.
|
|---|---|---|---|---|---|
|
Reports of Subjective Quality of Hearing as Assessed by the Bern Benefit Questionnaires
|
2.83 score on a scale
Standard Deviation 0.76
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fittingPopulation: Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears.
Ratings of speech in noise presented via loudspeakers using Gabriellson et al (1990) Ratings Scales. Scales include Clarity and Total Impression, and range from 1 to 10. The higher the rating, the better the Clarity and Total Impression.
Outcome measures
| Measure |
BiCROS With Beamformer
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement.
|
BiCROS Omni
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
|
Monaural With Beamformer
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement.
|
Monaural Omni
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
|
Unaided
n=18 Participants
No hearing aid fitting.
|
|---|---|---|---|---|---|
|
Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales
Clarity
|
6.8 score on a scale
Standard Deviation 2.4
|
5.2 score on a scale
Standard Deviation 2.8
|
6.5 score on a scale
Standard Deviation 2.3
|
4.8 score on a scale
Standard Deviation 2.8
|
3.7 score on a scale
Standard Deviation 3
|
|
Sound Quality Ratings for Total Impression and Clarity Using Gabriellson et al (1990) Ratings Scales
Total Impression
|
6.1 score on a scale
Standard Deviation 2.7
|
4.7 score on a scale
Standard Deviation 2.8
|
6 score on a scale
Standard Deviation 2.3
|
4.3 score on a scale
Standard Deviation 2.5
|
3.7 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fitting3 alternative forced choice (A, B, no preference or ABX) paradigm with three repetitions for speech in noise presented via loudsepakers
Outcome measures
| Measure |
BiCROS With Beamformer
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement.
|
BiCROS Omni
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
|
Monaural With Beamformer
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement.
|
Monaural Omni
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
|
Unaided
No hearing aid fitting.
|
|---|---|---|---|---|---|
|
Subjective Preference of Hearing Aid Condition
Omnidirectional
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Subjective Preference of Hearing Aid Condition
No preference
|
7 Participants
|
11 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Subjective Preference of Hearing Aid Condition
Monaural
|
6 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Subjective Preference of Hearing Aid Condition
BiCROS
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Subjective Preference of Hearing Aid Condition
Directional
|
0 Participants
|
0 Participants
|
16 Participants
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: At the appointment following the 4 weeks home trial each participant went on wearing the BiCROS fittingPopulation: Although each ear receives a different device configuration depending on the condition (except for the unaided condition), the participant is assigned as a whole, and assignment is not by ears.
Measuring listening effort for speech in multi-talker babble presented via loudspeaker. The scale ranges from 1 to 7, and a higher rating indicates less listening effort.
Outcome measures
| Measure |
BiCROS With Beamformer
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. A beamformer (directional microphone) will be enabled during this measurement.
|
BiCROS Omni
n=18 Participants
Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear. The microphones will be omnidirectional.
|
Monaural With Beamformer
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. A beamformer (directional microphone) will be enabled during the measurement.
|
Monaural Omni
n=18 Participants
Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear. The microphone will be omnidirectional.
|
Unaided
n=18 Participants
No hearing aid fitting.
|
|---|---|---|---|---|---|
|
Listening Effort in Noise Using 7 Point Scale (Holmes et. al., 2018)
|
3.75 score on a scale
Standard Deviation 1.8
|
4.9 score on a scale
Standard Deviation 1.9
|
3.9 score on a scale
Standard Deviation 1.6
|
5 score on a scale
Standard Deviation 1.5
|
5.7 score on a scale
Standard Deviation 1.8
|
Adverse Events
Complete Sample
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Complete Sample
n=22 participants at risk
All participants will perform the same tests in all conditions. The order of the conditions is randomized but will be performed in the same visit by each participant. Although each ear receives a different device configuration depending on the condition, the participant is assigned as a whole, and assignment is not by ears.
BiCROS fitting: Each participant will be fitted with the experimental CROS device on the unaidable ear and with a compatible hearing aid on the other ear.
Monaural hearing aid fitting: Each participant will be fitted with a hearing aid on the better hearing ear and no device on the unaidable ear.
Unaided condition: No intervention, the participants are not fitted with a CROS device and/or hearing aid.
Since all participants wore the same condition for the home trial and performed testing with all conditions in the appointment afterwards, Adverse Events are not reported by different arms.
|
|---|---|
|
Ear and labyrinth disorders
Ear infection
|
4.5%
1/22 • Number of events 1 • From the first appointment the participant was enrolled and assessed, until the last appointment that concluded the home trial and study participation. The whole duration was about 5-6 weeks per participant.
Studies involving the trial of a hearing aid are usually classified as low risk studies with low probability for serious adverse events or all-cause mortality.
|
|
Surgical and medical procedures
Early withdrawal (unrelated)
|
4.5%
1/22 • Number of events 1 • From the first appointment the participant was enrolled and assessed, until the last appointment that concluded the home trial and study participation. The whole duration was about 5-6 weeks per participant.
Studies involving the trial of a hearing aid are usually classified as low risk studies with low probability for serious adverse events or all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place